Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women

Infertility Clinical Trial

Official title:

Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03143114
• Other study ID #: WR3
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2020
• Source: Mansoura University
• Contact: Waleed El-refaie, Dr
• Phone: +201224515318
• Email: wrefaie[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.

Description:

All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 33 Years

Eligibility

Inclusion Criteria:

• Infertility for at least one year.

• Presence of intramural myoma.

• Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.

Exclusion Criteria:

• Age is < 20 or > 33 years.

• Symptomatic fibroid causing pelviabdominal swelling.

• Presence of > 2 myomas.

• Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).

• Presence of any other cause of infertility.

Related Conditions & MeSH terms

• Fibroid
• Infertility

Intervention

Procedure:
• Myomectomy
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Obstetrics and Gynecology Department in Mansoura University	Port Said

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women	6-8 weeks gestational age
Secondary	Miscarriage rate	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies	12 weeks gestational age